Naga Raju
Quality & Validation Engineer @Medtronic
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WORK HISTORY
Quality & Validation Engineer @Medtronic
TX, US
Perform IQ/OQ/PQ validations for dialysis and infusion systems under FDA 21 CFR 820 and ISO 13485.•Conduct functional and electrical safety testing following IEC 60601 standards.•Manage CAPA investigations, root cause analysis (FMEA/Fishbone), and corrective actions using TrackWise.•Maintain validation reports, calibration records, and device history files for audit readiness.•Collaborate with engineering and manufacturing teams to optimize equipment qualification processes.•Participate in supplier audits and ensure incoming materials meet quality specifications.•Supported process and product validation for Class implantable medical devices.•Performed first article inspections (FAI), in-process quality checks, and documentation under ISO 13485.•Assisted in developing risk management files and validation protocols for new product introduction (NPI).•Monitored CAPA progress and verified effectiveness through data trending and defect rate reduction.•Conducted internal audits and training sessions for manufacturing teams on cGMP practices.
EDUCATION
University of North Texas
Master's in biomedical engineering , Bioengineering and Biomedical Engineering
ABOUT NAGA RAJU
Biomedical professional with hands-on experience in servicing and managing critical hospital equipment. As a Biomedical Service Engineer, I worked extensively on oxygen concentrators, BiPAP machines, ECGs, ventilators, and infusion pumps—handling installation, calibration, troubleshooting, and preventive maintenance in compliance with ISO 13485 and FDA standards.At KIMS Hospital, I took on the role of Equipment Asset Manager, overseeing the complete lifecycle of biomedical assets. I managed inventory, coordinated with vendors for procurement and servicing, ensured regulatory compliance (NABH), and optimized equipment utilization through preventive maintenance and performance tracking.I’m passionate about improving healthcare delivery through reliable medical technology and efficient equipment management.
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